Agger Mikkel Pejstrup, Horning Maibritt, Carstensen Marcus Schultz, Danielsen Else Rubæk, Baandrup Anders Olhues, Nguyen Mai, Høgh Peter, Miskowiak Kamilla, Petersen Paul Michael, Madsen Kristoffer Hougaard, Kjær Troels Wesenberg
Department of Neurology, Zealand University Hospital, Roskilde, Denmark.
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Front Aging Neurosci. 2023 Oct 12;15:1250626. doi: 10.3389/fnagi.2023.1250626. eCollection 2023.
With no cure or effective treatment, the prevalence of patients with Alzheimer's disease (AD) is expected to intensify, thereby increasing the social and financial burden on society. Light-based 40 Hz brain stimulation is considered a novel treatment strategy for patients with AD that may alleviate some of this burden. The clinical trial ALZLIGHT will utilize a novel Light Therapy System (LTS). The LTS uses Invisible Spectral Flicker for non-invasive induction of 40 Hz neural activity. This protocol describes a trial evaluating the efficacy and safety of a light-based 40 Hz brain stimulation in patients with mild-to-moderate AD.
62 patients with mild-to-moderate AD will participate in a randomized, double-blinded, placebo-controlled, parallel-group, and single-center trial. The participants will partake in an enrollment period of 1 month, an intervention period of 6 months, and a 1.5-month post-interventional follow-up period. Prior to the baseline measurement (week 0), the patients will be randomized to either active or placebo intervention from baseline (week 0) to post-intervention follow-up (week 26).
This protocol describes a randomized, double-blinded, placebo-controlled clinical trial that may increase the understanding of the effect of gamma oscillations in the human brain and how it could be utilized as a novel and important tool for the treatment of AD. The effect is measured through a large, multidisciplinary assessment battery.www.ClinicalTrials.gov, (NCT05260177). Registered on March 2, 2022.
由于尚无治愈方法或有效治疗手段，预计阿尔茨海默病（AD）患者的患病率将上升，从而加重社会和财政负担。基于光的40Hz脑刺激被认为是一种针对AD患者的新型治疗策略，可能会减轻部分此类负担。临床试验ALZLIGHT将采用一种新型光疗系统（LTS）。该LTS使用不可见光谱闪烁来非侵入性地诱导40Hz神经活动。本方案描述了一项评估基于光的40Hz脑刺激对轻度至中度AD患者疗效和安全性的试验。
62例轻度至中度AD患者将参与一项随机、双盲、安慰剂对照、平行组单中心试验。参与者将经历1个月的入组期、6个月的干预期和1.5个月的干预后随访期。在基线测量（第0周）之前，患者将从基线（第0周）到干预后随访（第26周）被随机分配到活性或安慰剂干预组。
本方案描述了一项随机、双盲、安慰剂对照临床试验，该试验可能会增进对人脑伽马振荡效应的理解，以及它如何被用作治疗AD的一种新颖且重要的工具。通过大量多学科评估指标来衡量其效果。ClinicalTrials.gov（NCT05260177）。于2022年3月2日注册。
